| CTRI Number |
CTRI/2025/08/093425 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Yoga, Humming-Breath and Energy Centering Concentration Can Help Women Near Menopause Stay Calm and Healthy |
|
Scientific Title of Study
|
Effect of yoga based intervention with bhramari pranayama and chakra meditation on sympatho-vagal balance and psychological well being in peri-menopausal women -A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Jayachitra |
| Designation |
Ph.D Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
No.12 Vembuli amman koil Street,
West K.K.Nagar,
Chennai
No.12 Vembuli amman koil Street,
West K.K.Nagar,
Chennai 600 078
Chennai
TAMIL NADU
600078
India |
| Phone |
8610689273 |
| Fax |
|
| Email |
jaya_res@maher.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof DrV Subbulakshmi |
| Designation |
Principal , Faculty of Yoga Science and Therapy |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
No. 12 Vembuli amman koil street, West K.K.Nagar , Chennai
No. 12 Vembuli amman koil street, West K.K.Nagar , Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9176794264 |
| Fax |
|
| Email |
principal.yoga@maher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
S Jayachitra |
| Designation |
Ph.D Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
No. 12 Vembuli amman koil street, West K.K.Nagar , Chennai
No. 12 Vembuli amman koil street, West K.K.Nagar , Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
8610689273 |
| Fax |
|
| Email |
jaya_res@maher.ac.in |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy of Higher Education and Research No.12 Vembuli Amman koil Street, West K.K.Nagar, Chennai 600 078 |
|
|
Primary Sponsor
|
| Name |
S.Jayachitra |
| Address |
No.12 Vembuli Amman koil Street, West K.K.Nagar,
Chennai 78 |
| Type of Sponsor |
Other [Ph.D Scholar] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Subbulakshmi |
Meenakshi Academy of Higher Education and Research |
No.12 Vembuli amman koil street, K.K.Nagar, Chennai
Chennai
TAMIL NADU |
9176794264
principal.yoga@maher.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meenakshi Academy of Higher Education and Research Institutional Human EthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
They will be in active rest |
| Intervention |
Yogic practices, Bhramari pranayam and chakra meditation |
Loosening the joints , Bhramari pranayama and chakra meditation with bija mantra chanting relaxation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Middle aged women (40-50 years)with low quality of life (pretest with WHOQOL)
Willingness to participate in the studyand signing in the written consent form
No history of practicing yoga or other exercises
Living in Chennai citty only |
|
| ExclusionCriteria |
| Details |
Surgery, nerve blocks
Patients with complication caused by metabolic syndrome
Patients currently receiving treatment from AYUSH therapies
Subjects with ear, respiratory tract infections and recent history of surgery of ear/ vocal apparatus
Any other comorbidities , use of hypnotic medications or other drugs causing drowsiness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
What: ECG
When: Pre, Post and Follow up |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RMSSD,pNN50, LF/HF Ratio
Heart Rate
Blood Pressure
Perceived Stress Scale
WHO Quality of Life |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of a yoga based intervention incorporating Bhramari pranayama and chakra meditation on sympatho-vagal balance and psychological well being in perimenopausal women . Perimenopause is often accompanied by heightened stress, mood disturbance and autonomic imbalance due to hormonal fluctations. The intervention well be conducted over 3 months with regular session focussing on breathing techniques and meditative practices aimed at enhancing parasympathetic activity and emotional stability. Heart Rate Variability parameters including RMSSD,pNN50and LF/HF ratio will be used to assess autonomic nervous system balance while validated psychological scales such as the WHOQOL-BREF, Perceived Stress Scale will measure mental and emotional well being. A follow up assessment at 3 month post intervention will help to determine the sustainability of the effects. This research may offer evidence based support for the integration of yogic practice in managing menopausal transition symptoms and promoting holistic health in midlife women |